Treatment Registry of Alectinib in Anaplastic Lymphoma Kinase (ALK)-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer in Korea
- Registration Number
- NCT03271554
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
Alectinib was approved by the Ministry of Food and Drug Safety (MFDS) in Korea in Oct 2016. The purpose of this registry is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and effectiveness of the new drug so that the regulatory authority can manage the marketing approval properly.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 355
- Subjects who are administered alectinib at physician's discretion and fall into the approved indication in Korea.
- Hypersensitivity to alectinib or any ingredient of alectinib;
- Pregnant or lactating women;
- Pediatric subjects (age </=18 years);
- Due to the presence of lactose, subjects with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take alectinib.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Alectinib Alectinib Participants with ALK-positive, locally advanced or metastatic non-small cell lung cancer, who are treated with alectinib in accordance with local clinical practice and local labeling, are observed in this study.
- Primary Outcome Measures
Name Time Method Percentage of Participants with Adverse Events (AEs) Up to approximately 3 years An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. All AE events will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
- Secondary Outcome Measures
Name Time Method Complete Response (CR) Up to approximately 3 years CR will be determined according to RECIST v1,1 as assessed by physicians under routine clinical practice and is defined as disappearance of all target lesions and all nodes with short axis \<10 mm. Target lesions are those lesions with longest diameter \>/=10 mm and limits that are sufficiently well defined for their measurement to be considered reliable. Lymph nodes are target lesions if short-axis measures \>/=15 mm. Maximum number of selected target lesions is 5 per participant and 2 per organ.
Overall Response Rate (ORR) Up to approximately 3 years ORR will be determined according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 as assessed by physicians under routine clinical practice. Overall response rate was defined as the percentage of participants who had any evidence of Complete Response (CR) or Partial Response (PR): CR is defined as the disappearance of all target lesions and all nodes with short axis \<10 millimeter (mm); PR is defined as \>/=30% decrease in the sum of the longest diameter of target lesions. Target lesions are those lesions with longest diameter \>/=10 mm and limits that are sufficiently well defined for their measurement to be considered reliable. Lymph nodes are target lesions if short-axis measures \>/=15 mm. Maximum number of selected target lesions is 5 per participant and 2 per organ. Overall Response (OR) = CR + PR.
Percentage of Participants with Stable Disease (SD) Up to approximately 3 years SD will be determined according to RECIST v1.1 as assessed by physicians under routine clinical practice and is defined as neither response nor progression. Response is defined as at least \>/=30% decrease in the sum of the longest diameter of target lesions. Progression is defined as \>/= 20% increase in the sum of target lesions taking as reference the smallest sum measured during follow-up and \>/= 5 mm in absolute value. Target lesions are those lesions with longest diameter \>/=10 mm and limits that are sufficiently well defined for their measurement to be considered reliable. Lymph nodes are target lesions if short-axis measures \>/=15 mm. Maximum number of selected target lesions is 5 per participant and 2 per organ.
Percentage of Participants with Partial Response (PR) Up to approximately 3 years PR will be determined according to RECIST v1.1 as assessed by physicians under routine clinical practice and is defined as \>/=30% decrease in the sum of the longest diameter of target lesions. Target lesions are those lesions with longest diameter \>/=10 mm and limits that are sufficiently well defined for their measurement to be considered reliable. Lymph nodes are target lesions if short-axis measures \>/=15 mm. Maximum number of selected target lesions is 5 per participant and 2 per organ.
Percentage of Participants with Progressive Disease (PD) Up to approximately 3 years PD will be determined according to RECIST v1.1 as assessed by physicians under routine clinical practice and is defined as \>/=20% increase in the sum of target lesions taking as reference the smallest sum measured during follow-up and \>/= 5 mm in absolute value. Target lesions are those lesions with longest diameter \>/=10 mm and limits that are sufficiently well defined for their measurement to be considered reliable. Lymph nodes are target lesions if short-axis measures \>/=15 mm. Maximum number of selected target lesions is 5 per participant and 2 per organ.
Trial Locations
- Locations (36)
Inje University Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
Dong-A University Hospital
🇰🇷Busan, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Kosin University Gospel Hospital
🇰🇷Busan, Korea, Republic of
Dongnam Institute of Radiological & Medical Sciences
🇰🇷Busan, Korea, Republic of
Chungbuk National University Hospital
🇰🇷Cheongju-si, Korea, Republic of
Kyungpook National University Chilgok Hospital
🇰🇷Daegu, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Daegu Catholic University Medical Center
🇰🇷Daegu, Korea, Republic of
Konyang University Hospital
🇰🇷Daejeon, Korea, Republic of
Yonsei University Wonju Severance Christian Hospital
🇰🇷Wonju-Si, Korea, Republic of
Uijeongbu St. Mary's Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
CHA Bundang Medical Center
🇰🇷Gyeonggi-do, Korea, Republic of
Hallym University Sacred Heart Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Bucheon St Mary's hospital
🇰🇷Gyeonggi-do, Korea, Republic of
St. Vincent's Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Gyeongsangnam-do, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
Inje University, Sanggye-Paik Hospital
🇰🇷Seoul, Korea, Republic of
Chonnam National University Hwasun Hospital
🇰🇷Jeollanam-do, Korea, Republic of
Kyung Hee University Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Gangdong Kyung Hee University Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Ewha Womans University Mokdong Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Inje University Ilsan Paik Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Chonbuk National University Hospital
🇰🇷Jeollabuk-do, Korea, Republic of
Catholic Univ. of Incheon St.Mary's Hospital
🇰🇷Incheon, Korea, Republic of
Severance Hospital, Yonsei University
🇰🇷Seoul, Korea, Republic of
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
Soon Chun Hyang University Hospital; Department of Pulmonology and Allergy
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of